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Patients' and medical practitioners' approaches to the use of prescribed steroids in asthma : the potential for informed choiceStevenson, Fiona Anne January 1997 (has links)
Recent changes in legislation and access to information, through sources such as the media, may have influenced peoples' expectations for information about their prescribed medication. As a result, health care professionals may perceive an increased pressure to provide information. A case study approach was employed to examine the sources and scope of information patients draw upon when they are prescribed oral steroids for asthma. The aim was to examine the extent to which patients can be said to exercise an `informed choice' when they take prescribed medication. The role and importance of GPs (general practitioners) in informing the choices patients make was also examined. Both qualitative and quantitative methods were employed. Interviews conducted with both patients and GPs indicated `gaps' in understanding. Although the GP was the preferred source of information, patients reported that the choices they made were based on information from a range of sources. General practitioners justified not providing information to patients so as to `protect' patients from knowledge of side effects. However, there was some awareness of the range of sources of information used by patients. A vignette technique was employed to further investigate GPs' recognition and understanding of the range of sources of information patients' use to inform the choices they make. Approximately half of the GPs who responded to the vignette recognised the influences presented. General practitioners who had been practising for a shorter period of time were significantly more likely to recognise these influences. The conclusions draw on the literature of the sociology of the professions. In spite of the way in which the Government has sought to encourage patients to act as consumers, the state has also continued to endorse GPs right to make decisions concerning the level of information to provide. If GPs do not believe it is in the interests of patients to be provided with information to make choices about their medications then the information available to patients may be limited. This will have an impact on the ease with which patients may make `medically' informed choices about their prescribed medication. Only when the communication between patients and GPs improves, will it be possible for a relationship to develop where patients may be assured of gaining information from their GP at the level they feel is appropriate to enable them to make informed choices about their medication.
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A case study to assess participants' perceptions on voluntariness and motivations for participating in a clinical trial in Zimbabwe.Mutenherwa, Farirai. 14 June 2013 (has links)
Introduction: There is little empirical evidence on voluntariness of participation in clinical
trials due to absence of acceptable measures and universally accepted conceptual frameworks
of voluntariness. Methods: A cross-sectional study was conducted in Zimbabwe to examine
participants’ motivations, levels of voluntariness and perceptions about the effect of offers,
pressures and threats on decision making. One hundred participants were recruited from an
ongoing diagnostic trial. Questionnaires adapted from published research, the Perceived
Coercion Scale and Voluntariness Ladder were used for data collection. Results: The need to
access diagnostic services and treatment for tuberculosis was the main motivation for
enrolment in the trial. Participants were not coerced to particpate in the trial but were offered
bus fare. The offer had no effect on their decision to enroll in the trial. Conclusion:
Immediate health benefits have a key impact on participants’ decisions to enrol in a clinical
trial of a diagnostic technique. A comprehensive conceptual framework together with
validated tools for assessing voluntariness in African contexts should be developed. / Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2012.
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Assessing participants' understanding and voluntariness of informed consent in a clinical trial in Nigeria.Adewale, Babatunde. January 2012 (has links)
Introduction: Citizens of developing countries are often in vulnerable situations because of illiteracy, unfamiliarity with medical interventions, effects of war resulting in famine, and extreme poverty. The health-related conditions that arise out of these situations however make research in these populations vital and increasing funding for research on diseases that affect the world 's poor is making such research possible. The resulting tension between the need for research and the possibility of exploitation of participants' vulnerability, mandates the development of reliable ways of ensuring that participants' consent is voluntary, adequately informed and well understood. The Nuremberg Code emphasises the requirement of voluntariness in informed consent by insisting that participants should be able to exercise freedom of choice without the intervention of any element of force, fraud , deceit, duress, or other forms of constraint
or coercion. Aim: This study assessed research participants' understanding and voluntariness of informed consent in a clinical trial. Methods: The study design was a cross-sectional analysis of the informed consent process. It consisted of qualitative and quantitative components. It was a cross-sectional survey of 75 research participants in a malaria clinical trial using questionnaires in the from of forced-choice check lists and patient self-report to assess voluntariness and understanding of informed consent. Data were analysed using SPSS V 17. Results: All the respondents involved in the clinical trial gave consent before they were recruited. The reasons for consenting to participate in the clinical trial ranged from the
opportunity to get treatment (28%), opportunity for diagnosis of ailments (32%), to prevent illness (36%) and to receive information about medical care (4%). The major benefits participants attributed to taking part in the research were the opportunity to obtain treatment (59%), diagnostic tests (35%) and education (6%). Among the research participants, 10.7% believed that they should be paid for participation and about 8% felt that payment could influence their decision to participate because it could act as a motivation. They could however not proffer an amount that they would consider significant enough to influence their decision. There was no significant association between factors that influenced participation and age (p=0.533), sex (p=0.342), education (p=0.078), religion (p=0.144) and marital status (p=0.239). Almost all (98.7%)
participants claimed that they had understood the information given to them during the consent procedure and they all gave consent without consulting anybody apart from the medical personnel.The majority of respondents - 74 (98.7%) - stated that they were not allowed to go home with the informed consent document, while 1(1 .3%) of the respondents said there was no need to go home with the informed consent document. In the assessment of understanding using the forced-choice checklist, however, only 37% understood issues concerning randomization of participants and only 28.8% understood issues about compensation for research related injury. Discussion and Conclusion: In this study, the voluntariness of participants was influenced by factors related to the benefits accrued through participation. The need for
participants to make free and informed choices based on adequate information given by the investigator cannot but be emphasized as a right and not a privilege. In light of the limited understanding about randomization and injury compensation identified in this study, there is a need for additional protection of vulnerable populations. This could be in the form of allowing adequate time to enable the improvement of participants' understanding of the consent form, using innovative ways of explaining complex concepts such as randomization, and providing the necessary support to facilitate participants' right to self-decision, except when they are incapable of consenting. / Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2012.
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Exploring research participant's perceptions and comprehension of the informed consent process in a pre-exposure HIV prevention study in Zimbabwe : a case study.Ruzariro, Sithembile. January 2012 (has links)
Background. An inherent challenge in HIV prevention studies is making sure that trial participants
understand the information. This study explored trial participants’ perceptions and
comprehension of the informed consent process in a pre-exposure HIV prevention
study. Method. Face-to-face in-depth interviews, using a study guide, were held with twenty
interviewees purposively selected from ex-participants of an HIV prevention study.
Audio-recorded data were transcribed, translated, coded using NVivo 8, and analysed
according to themes. Results. The participants were all women between the ages of 18 and 40. Participants felt that
key information had been given during the informed consent process. Most felt that the
process of obtaining informed consent was rushed with some participants citing a need
for more time to make a decision regarding participation. Some participants felt
pressured to sign consent forms. Some found it difficult to ask questions and mixed
feelings existed on male partner involvement in the decision-making process.
Conclusions: Participants experienced the consent process as rushed and most only fully
comprehended study concepts with time. Their concerns necessitate the reassessment
of informed consent processes in a developing world setting. / Thesis (M.Soc.Sc.)-University of KwaZulu-Natal, Pietermaritzburg, 2012.
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In the name of research : Essays on the ethical treatment of human research subjectsBelfrage, Sara January 2014 (has links)
Essay 1: Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. We then point to some of the issues that need to be addressed for a systematic approach to the ethics of traffic research. Essay 2: The requirement of always obtaining participants’ informed consent in research with human subjects cannot always be met, for a variety of reasons. In this paper, research situations where informed consent is unobtainable are described and categorised. Some of these kinds of situations, common in biomedicine and psychology, have been previously much discussed, whereas others, more prevalent in for example infrastructure research, introduce new perspectives. The advancement of new technology may lead to an increase in research of these kinds. The paper also provides a review of methods intended to compensate for a lack of consent and their applicability and usefulness for the different categories of situations are discussed, thereby providing insights into one important aspect of relevance for the question of permitting research without informed consent: how well that which informed consent is meant to safeguard can be achieved by other means. Essay 3: This paper starts with the assumption that it is morally problematic when people in need are offered money in exchange for research participation if the amount offered is unfair. Such offers are called “coercive”, and the degree of coerciveness is said to be determined by the offer’s potential to cause exploitation and its irresistibility. Depending on what view we take on the possibility to compensate for the sacrifices made by research participants, a wish to avoid “coercive offers” leads to policy recommendations concerning payment for participation. For sacrifices considered compensable we ought to offer either no payment or payment at a level deemed fair, while for sacrifices deemed incompensable we always ought to offer no payment. Essay 4: It is commonly thought that transactions that are the result of voluntary gift-giving do not constitute exploitation. This paper argues that exploitation is indeed possible in such situations, by showing how gift-giving can fulfil the two commonly proposed criteria for exploitation, namely that in an interaction between two persons one receives disproportionally little and the other disproportionally much of the resulting benefits, and that this disproportion is caused by the latter making inappropriate use of a disadvantage of the former. A theoretical approach to what such inappropriate use would amount to in cases of gift-giving is lacking. The paper therefore aims at spelling out such an approach. The method of reflective equilibrium inspires this endeavour, which proceeds by testing intuitions about examples that embody a set of possible conditions. It is concluded that three of the conditions are necessary for exploitation of gift-giving, namely (1) the giver incurs a loss, (2) the recipient has aimed for the gift, and (3) the gift is undeserved. / <p>QC 20140407</p>
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Informuoto sutikimo doktrinos taikymas nėščiųjų pacienčių požiūriu / Application of the doctrine of informed consent from viewpoint of pregnant patientsPoškienė, Ingrida 03 August 2007 (has links)
Darbo tikslas: Įvertinti nėščiųjų pacienčių požiūrį į informuoto sutikimo doktrinos taikymą stacionarią pagalbą teikiančioje gydymo įstaigoje.
Uždaviniai: Įvertinti nėščiųjų pacienčių informuotumą apie jų teises gydymo įstaigoje. Įvertinti pacienčių požiūrį į rašytinio sutikimo davimo procedūrą. Nustatyti ryšį tarp pacienčių savo sveikatos vertinimo, išsilavinimo ir jų nuomonės apie informuoto sutikimo doktrinos taikymą.
Tyrimo metodika: Atlikta anoniminė anketinė KMUK Akušerijos–ginekologijos klinikos Akušerijos skyriaus pacienčių apklausa. Buvo apklaustos 304 nėščios pacientės (atsako dažnis 84,4 proc.). Duomenų analizei naudota SPSS 10.0 statistinės analizės paketas.
Rezultatai: Atlikus tyrimą paaiškėjo, jog Pacientų teisių ir žalos sveikatai atlyginimo įstatymą žinojo 76,3 proc. respondenčių. Dauguma pacienčių (98,0 proc.) tvirtino, žinančios, jog turi teisę į informaciją apie savo sveikatos būklę. 92,6 proc. respondenčių nurodė, kad buvo supažindintos su visomis procedūromis, kurios bus atliekamos įstaigoje. Dauguma pacienčių (92,4 proc.) buvo patenkintos gauta informacija iš gydytojų. Statistiškai reikšmingai didesnė dalis pacienčių tvirtino, kad suprantamą informaciją apie jų sveikatos būklę: ligos diagnozę, gydymo metodus ir gydymo eigą, gydymo prognozę ir galimus gydymo rezultatus, galimus alternatyvius gydymo metodus joms suteikė gydytojas lyginant su pacientėmis, tvirtinusiomis, jog minėtą informaciją suprantamai pateikė akušerė (p<0,001). 77,9 proc. nėščiųjų... [toliau žr. visą tekstą] / Aim of the study. To evaluate the pregnant patients’ opinion about application of the doctrine of informed consent.
Objectives: 1. To evaluate knowledge of pregnant patient about their rights in the health care institution. 2. To evaluate patients’ opinion about procedure of the written consent. 3. To compare patients’ opinion about application of the doctrine of informed consent with self -assessed health and education.
Methods. Anonymous survey of 304 pregnant patients (response rate – 84.4 percent) at Kaunas Medical University Clinic was carried out. SPSS 10.0 version of statistic analysis program was used to process the data.
Results. Study revealed that the Law on patients‘rights and the compensation of the damage inflicted upon patients’ heath were known for 76.3% of the respondents. The majority of patients (98.0%) maintained aware about the right to information about their health status. 92.6% of respondents claimed, that they were informed about all procedure performed in the institution. The majority of patients (92.4%) were satisfied with the information delivered by the physician. Statistically significant higher part of patients maintained, that comprehensible information about their health: diagnosis, treatment, prognosis, results was delivered by the physician in comparison with the patients who emphasised that given information was provided by obstetrician (p<0,001). 77.9% of pregnant revealed being satisfied with the informed consent procedure. 22.1% of... [to full text]
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Onkologinėmis ligomis sergančių pacientų nuomonė apie informuoto sutikimo doktrinos taikymą sveikatos priežiūros įstaigoje / Oncology patients` opinion about application of the doctrine of informed consent in the health care institutionRaudonytė, Aušra 19 June 2008 (has links)
Darbo tikslas. Įvertinti onkologinėmis ligomis sergančių pacientų nuomonę apie informuoto sutikimo doktrinos taikymą N sveikatos priežiūros įstaigoje.
Uždaviniai. Įvertinti pacientų informuotumą apie rašytinio sutikimo doktrinos paskirtį sveikatos priežiūros įstaigoje. Nustatyti ryšį tarp onkologinėmis ligomis sergančių pacientų požiūrio į informuoto sutikimo doktrinos taikymą bei pacientų lyties ir išsimokslinimo. Nustatyti ryšį tarp pacientų pasitenkinimo gydytojų suteikiama informacija apie ligą ir jų nuomonės apie informuoto sutikimo doktrinos reikalingumą.
Tyrimo metodika. N sveikatos priežiūros įstaigoje atlikta anoniminė anketinė 250 pacientų apklausa (atsako dažnis – 75,7 proc.). Duomenų analizei naudotas SPSS 13.0 statistinės analizės paketas. Diagramos ir lentelės parengtos Microsoft Excel 2003 programa.
Rezultatai. Beveik pusė visų apklaustųjų (44,8 proc.) manė, kad sveikatos priežiūros įstaigoje pacientams pasirašyti pateikiamos asmens informuoto sutikimo formos paskirtis - apsaugoti sveikatos priežiūros specialistus nuo galimų pacientų pretenzijų, 35,6 proc. respondentų nuomone, informuoto sutikimo forma padeda pacientams išreikšti su jų gydymu susijusį apsisprendimą, 18,8 proc. apklaustųjų manė, kad tai formali procedūra. Didesnė dalis vyrų (34,5 proc.) nei moterų (18,4 proc.) visai neskaitė ligoninėje jiems pateiktų asmens informuoto sutikimo formų (p<0,01). Statistiškai reikšmingai daugiau respondentų, turėjusių nebaigtą vidurinį ar pradinį išsimokslinimą (24... [toliau žr. visą tekstą] / Aim of the study. To evaluate the oncology patients` opinion about application of the doctrine of informed consent in the health care institution.
Objectives. To evaluate patients` knowledge about the purpose of the doctrine of informed consent at the health care institution. To identify associations between oncology patients` opinion about application of the doctrine of informed consent, patients` gender and education. To identify associations between patients` satisfaction with given information about their disease and patients` opinion about the necessity of the doctrine of informed consent.
Methods. Anonymous survey of 250 oncology patients (response rate – 75.7%) in health care institution was carried out. SPSS 13.0 version of statistic analysis program was used to process the data. Diagrams and tables were prepared using Microsoft Excel 2003 program.
Results. Nearly half of the survey participants (44.8%) evaluated written informed consent procedure as protection instrument to the health care specialists. More than the one third (35.6%) of the participants thought that the doctrine of informed consent helped them to express their decision, to 18.8% of the survey participants the doctrine was formal procedure. Statistically significantly bigger proportion of male (34.5%) than female (18.4%) claimed that they haven`t read the text of signed informed consent form at all (p<0.01). Statistically significantly higher proportion of respondents with the lowest level of... [to full text]
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Ar paciento standartnės formos pasirašymas laikytinas pakankamu informuoto sutikimo davimu? / Does the signing of patients standard form is considered sufficient for informed consent?Radzevičiūtė, Inga 08 August 2008 (has links)
Darbe nagrinejamas informuotas paciento sutikimas medicininio gydymo kontekste, sutikimui keliami reikalavimai, teisės aktų, susijusių su pacientų teisėmis normos. / The aim of this work was to answer the legal question whether rendering of the standard consent form to the patient and signing of it can be regarded as a proper informed consent.The growing availability of medical information sources, involvement of mass media and TV programs has enabled patients to get more information about medical care, so as a consequence, informed decision making became a central topic in doctor – patient communication.
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Pacientų nuomonė apie konfidencialumo principo taikymą n gydymo įstaigoje / Patients‘ opinion about the application of confidentiality principle in medical institution nVenclovaitė, Rūta 15 June 2009 (has links)
Darbo tikslas. Įvertinti pacientų nuomonę apie konfidencialumo principo taikymą gydymo įstaigoje.
Uždaviniai. Įvertinti pacientų informuotumą apie konfidencialumo principo taikymą sveikatos priežiūros įstaigoje. Išaiškinti pacientų požiūrį į konfidencialumo principo taikymą sveikatos priežiūros įstaigoje ir nustatyti ryšį su pacientų lytimi ir išsimokslinimu.
Tyrimo metodika. N sveikatos priežiūros įstaigoje atlikta anoniminė anketinė 303 pacientų apklausa (atsako dažnis – 86,6 proc.) Duomenų analizei naudotas SPSS 13.0 statistinės analizės paketas. Diagramos ir lentelės parengtos Microsoft Excel 2007 programa.
Rezultatai. 56,8 proc. tyrimo dalyvių teigė, jog perskaitė visas pasirašyti pateiktas formas, 28,7 proc. respondentų tvirtino, kad perskaitė kai kurias jiems pateiktas informavimo/sutiki-mo formas. 66,7 proc. respondentų teigė, kad prieš pasirašydami visiškai aiškiai žinojo dėl ko duoda sutikimą, 19,1 proc. respondentų prisipažino, jog kai kas buvo neaišku, ir 14,2 proc. respondentų nurodė, jog nesuprato su kuo sutinka, tačiau pasirašė, nes taip reikia. 52,5 proc. skaičiusių informavimo formas respondentų nurodė, jog pateiktoje informuoto sutikimo formoje buvo aiškūs visi teiginiai, 36,7 proc. respondentų dauguma teiginių buvo aiškūs. Mažiau nei pusė respondentų (45,9 proc.) manė, jog informacija apie ligą ir medicininius tyrimus yra įslaptinta, su šiuo teiginiu nesutiko 26,1 proc. respondentų. Nustatytas statistiškai reikšmingas ryšys tarp pacientų išsimokslinimo ir... [toliau žr. visą tekstą] / Aim of the study. To evaluate patients' opinion about the application of confidentiality principle in medical institution.
Objectives. To evaluate patients' awareness about the application of confidentiality principle in health care institution. To find out patients‘ attitude towards the application of confidentiality principle in health care institution and to determine its relationship with patients‘ gender and education.
Methods. An anonymous survey of 303 patients using questionnaires (response frequency – 86.6 %) ¬was carried out in the health care institution N. Data analysis used the SPSS 13.0 statistical analysis package. Charts and tables were prepared using Microsoft Excel 2007.
Results. 56.8 % of the survey participants told that they had read all the forms presented to be signed, 28.7 % of the respondents claimed that they had read some of the forms of information/consent presented to be signed. 66.7 % of the respondents affirmed, that before signing they knew absolutely clearly why they had given their consent, 19.1 % of the respondents admitted that some things were unclear, and 14.2 % of the respondents told that they had not understood why they had given their consent; however, they had signed the form because it was necessary. 52.5 % of the respondents who had read the forms of information claimed that all the propositions of the form of informed consent were clear, 36.7 % of the respondents had understood most of the propositions. Less than half of the... [to full text]
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Knowledge translation and exchange in the Canadian microbial food safety sectorWolfe, Dianna Marie 14 December 2012 (has links)
Knowledge translation and exchange (KTE) is integral to the formation of evidence-informed policy. Prior to the work presented in this dissertation, a significant body of literature existed in the healthcare field regarding research-to-policy KTE; however, little was known about KTE between researchers and policymakers in the Canadian food safety system or the context-specific barriers that influence KTE. A mixed-methods approach was used, grounded in concepts from the healthcare literature, to explore Canadian food safety researchers’ KTE awareness and activities with policymakers, the barriers hindering KTE engagement and success, and timing and informational disparities between research and policy needs that may hinder KTE success. Canadian food safety researcher awareness of and engagement in KTE activities with policymakers was high. However engagement in activities identified as having the greatest potential for KTE success—i.e., collaboration with policymakers at all stages of the research process, provision of syntheses such as systematic reviews, and provision of a searchable database of research findings—was low relative to end-of-research dissemination of findings to policymakers. Several barriers were identified that limited KTE engagement and success from the researcher’s perspective, including an inability to identify relevant policymakers, high policymaker turnover, a lack of resources and support in the research organization, a perceived lack of KTE skills on the part of researchers, and an inability to break free from traditional publish-or-perish research roles. Apparent informational disconnects (i.e., research output not meeting policymakers’ apparent informational needs) were identified that may further hinder KTE and evidence-informed policymaking. While new methodologies, such as systematic review, have been adapted for food safety research, boosting researchers’ potential ability to produce policy-relevant evidence, a cultural shift must occur in research and policymaking organizations, if sustained KTE is to be successful. As well, significant future investment must be made on the part of research organizations and policymakers, if KTE barriers are to be mitigated. Future research should evaluate KTE tools (e.g., sustained linkages between researchers and policymakers, provision of syntheses, provision of access to a database of research findings) to identify specific methods that may facilitate research use in food safety policymaking. / Blake Graham Fellowship, Canadian Institutes of Health Research, Public Health Agency of Canada
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